Posts Tagged Science
Hang on a minute. Were not the EU and its Member States supposed to be precaution obsessed? Don’t the EU and its Member States alike adopt bans on all things GMO for no other reason than that they simply do not want them? How then can the CJEU hold in C-111/16 Fidenato that Member States do not have the option of adopting, in accordance with Article 54 of Regulation 178/2002, the EU’s general food safety law, interim emergency measures solely on the basis of the precautionary principle?
The reason lies in pre-emption, aka exhaustion, and in the balance between EU and national risk management which EU law strikes in the specific field of GM cultivation. Of note is that in the meantime most biotech companies have given up on cultivation of GM varieties in the EU.
As extremely well summarised by Bobek AG in his Opinion in the case, the formulation of the relevant EU legislation is such as to provide that post EU authorisation (here: of genetically modified maize MON 810) Member States may only take emergency measures where the continued cultivation of the approved products is ‘likely to constitute a serious risk’. While the precautionary principle may play its role fully at the level of the EU’s risk management preceding authorisation, and indeed post such authorisation, too, Member States are given less leeway in their national emergency measures. In prescribing these rules, the EU safeguards the harmonised approach to the GM varieties at issue.
(Mr Fidenato nb is something of a cause celebre among the GM community). Please note, again, that the case concerns the growing (‘cultivation’) of GM crops. Not the import, export or use of products containing GM.
Finally it is important to point out that the Court does not equate precaution with the absence of science. It is the degree of scientific certainty here which is relevant, not the absence ‘v’ presence thereof.
The CJEU held yesterday in Case C-296/16P Dextro Energy (text of judgment available in French and German only at the time of posting), an appeal against the General Court’s ruling in T-100/15. The General Court had declined to annul the European Commission Regulation which refused to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. Dextro Energy had wanted to include health claims such as ‘glucose supports normal physical activity’ and ‘glucose contributes to normal muscle function’. The EC had refused: citing (in Regulation 1215/8)
‘Pursuant to Articles 6(1) and 13(1) of Regulation … No 1924/2006 health claims need to be based on generally accepted scientific evidence. Authorisation may also legitimately be withheld if health claims do not comply with other general and specific requirements of Regulation … No 1924/2006, even in the case of a favourable scientific assessment by [EFSA]. Health claims inconsistent with generally accepted nutrition and health principles should not be made. [EFSA] concluded that a cause and effect relationship has been established between the consumption of glucose and contribution to energy-yielding metabolism. However, the use of such a health claim would convey a conflicting and confusing message to consumers, because it would encourage consumption of sugars for which, on the basis of generally accepted scientific advance, national and international authorities inform the consumer that their intake should be reduced. Therefore, such a health claim does not comply with point (a) of the second paragraph of Article 3 of Regulation … No 1924/2006 which foresees that the use of claims should not be ambiguous or misleading. Furthermore, even if the concerned health claim was to be authorised only under specific conditions of use and/or accompanied by additional statements or warnings, it would not be sufficient to alleviate the confusion of the consumer, and consequently the claim should not be authorised.’
The General Court performed its standard review in the face of a wide discretionary room for manoeuvre for the EC, and decided the EC had not exceeded its authority in holding as it did – even in the face of more lenient EFSA recommendations. The Court of Justice has now entirely sided with the General Court. The Judgment is a good reminder of aforementioned standard test (no de novo or merits review; annulment in the event of manifest transgression of power or error in judgment only), and readers best refer to reading the judgment itself.
One consideration however, I should like to highlight: Dextro Energy had suggested the health claims needed to be assessed in light of the target group (determined in the product’s advertising), which, it was suggested, were physically active people for whom consumption of the glucose tablets in question is not harmless. The Court rejected this approach: the population as a whole, for whom the product is available, are the group which the EC justifiably seeks to protect. The manufacturer’s professed target group is not the relevant group to consider (do bear in mind that this is a product which is widely available and not restricted in any way at points of sale):
At 76-77: si les allégations de santé en cause étaient autorisées, elles s’adresseraient à la population en général, pouvant ainsi encourager la consommation de sucres par les personnes autres que les hommes et les femmes bien entraînés. Dans ces conditions, le Tribunal n’a pas commis d’erreur de droit lorsqu’il a rejeté, au point 57 de l’arrêt attaqué, l’argument de Dextro Energy, selon lequel c’était le groupe cible qui importait aux fins de l’appréciation des allégations de santé en cause.
I reported at the time on the General Court‘s decision in Dyson. The CJEU yesterday in Case -44/16P agreed, albeit in less prosaic terms than my earlier post, that the Court’s reasoning was wanting. The case now goes back to the General Court to reconsider those pleas made by Dyson which the Court considers to have been insufficiently answered.
Of most interest to readers of this blog is the argument re proof, science and procedure (at 72 ff): According to the Commission, Dyson does not explain in what way the development of a test with a loaded receptacle would have been more proportionate. The Commission submits that it was not obliged to show that no better test method could be developed, and that it was on the contrary for Dyson to prove that a more appropriate test method existed, which in the view of the General Court it failed to do.
The Court of Justice agrees that the General Court’s entertainment of this question is wanting – the particular parameter was required under the delegating Directive, alleged absence of a reliable test is not enough to ignore it. That is not to say, that upon reconsideration the eventual General Court’s answer may not be the same.
Update 27 April 2017: the CJEU held today, largely along the lines of the AG.
Anyone with an interest in mutual recognition, risk and trade, and the exhaustive effect of EU food law should consult the Opinion of Advocate General Bobek in Case C-672/15 Noria Distribution, which was released last week.
Noria Distribution SARL (‘Noria’) is being prosecuted for having sold in France food supplements containing vitamins and minerals in quantities exceeding maxima set under French law. Noria does not deny doing so. However, it argues in response that those maxima are not valid because they were set in breach of EU law. Noria adds that it produces and sells the same products lawfully in other Member States.
The Advocate General suggests EU law on the issue is not exhaustive. Member States can set their own limits. An issue under discussion in the national proceeding is the origin (national or international) of the science underpinning the limits. The AG justifiably advises that the origin of the data is irrelevant. EU law concern is not about the details of bibliographies. It is rather that restrictions be justified on the basis of solid science demonstrating real risk or at least the inability to exclude risk: whether this is the case is for the national court to determine. The precautionary principle can be invoked by the Member States in setting their limits.
The AG’s approach is very sensible. Without losing himself in lengthy discussion, he reminds the national courts and authorities of the benchmarks for risk management.
Do the newly negotiated EU rules on endocrine disruptors illustrate regulatory chill /the ‘freezing effect’ of international trade law?
The new European Commission proposals on endoctrine disruptors are, of course’ ‘science based’. It has been reported (EurActiv, 12 December 2016 and last consulted by me on 13 December) that publication of the proposals was followed by a closed door meeting (minutes of which were released only after a freedom of information request) between the EC and a select number of countries (US, Canada, Argentina, Brazil and Uruguay on 13 July this year). Discussion centered around the potential WTO incompatibility of parts of the EC proposal, particularly those surrounding the tolerance levels for endocrine disruptors present in imported substances (food and feed in particularly). The EC reportedly are prepared to replace “negligible exposure” with “negligible risk from exposure”. The EC defend the latter, arguing it might even ban more, rather than less imported substances: for even if there is only negligible exposure, that exposure may still be a risk. Opponents suggest that the insertion of a risk approach has sacrified precaution on the altar of science.
A few comments.
Firstly, the report (and potentially even the EC itself) repeats the misleading assertion that the debate concerns either science or precaution. Precaution is NOT unscientific. The very trigger of the precautionary approach is science.
Next, the case is reported at a time a lot of people are getting jittery about the regulatory co-operation mechanisms in free trade agreements such as CETA and TTIP. The meeting and the subsequent EC reaction to our trading partners’ comments, would then represent an example of the ‘freezing effect’ in international trade: with our trading partners flying the flag of WTO incompatibility, the EU would then have caved in to threats of litigation in Geneva. Yet in reality WTO input by fellow WTO Members is at least as old as the WTO itself, indeed it predates it. The 1978 Tokyo Standards Code already obliged the then GATT Contracting Parties to notify their draft standards to the GATT Secretariat. The very point of notification and transparency is that the issues raised are being discussed and may indeed lead to the draft standard being adopted. Changes made to REACH, to name but one example, reflected concerns of fellow WTO Members and REACH can hardly be said to pander to industry’s demands.
However there needs to be one core appreciation in this process: just as notification serves transparency (anyone can consult the TBT notification gateway to review draft measures that have been notified), so too should the process of review after reception of the comments, be conducted in a transparent manner. This clearly has not happened here. By conducting these meetings in private, and by refusing to release the minutes until prompted to do so, EC services have given the impression that there is more than meets the eye. In times where even CETA has not yet been ratified, that is most definitely the wrong approach.
Belgian parliamentary watchdog upholds unstunned slaughter, protects Shechita (kosher) and Zabihah (halal).
Update 8 May 2017. Following a botched attempt at reconciliation, Parliament is now debating a ban to enter into force 1 January 2019.
Update 28 July 2016 A Brussels Court has referred to the CJEU for interpretation of the EU Regulation, questioning whether the Regulation’s regime may itself be incompatible with the ECHR. Update 16 September 2016 the case number is C-426/16. See here for the questions referred (in Dutch).
The Belgian Council of State, chamber of legislation (in the title I call it a ‘parliamentary watchdog: for that is what it is. By issuing prior opinions on the legality of legislative initiative it guards against illegal Statute) has opined that a private members bill banning unstunned slaughter, does not pass the ECHR test.
A European Regulation (1099/2009) provides for an unclear, and conditional, exemption for religious (regularly rather offendingly called ‘ritual’) slaughter. Practised in particular by the Jewish (Shechita; leading to ‘kosher’ meat) and Muslim (Zabihah; with halal meat) faith, a core aspect of the practice is that animals are not stunned prior to slaughter. The science on the effect of stunned or unstunned slaugther is equivocal. What is certain is that neither stunned nor unstunned slaughter, when carried out incorrectly (well documented in the case of stunned slaughter) aids the welfare of the animal.
Religious slaughter falls squarely within the European Convention of Human Rights Article 9’s freedom of religious expression. Hence the Council of State summarily (its conciseness is rather attractive) reviews the ECtHR’s case-law and concludes that the proposed ban would be both unconstitutional and clearly against the provisions of the ECHR.
On the EU Regulation front, I believe the EU rules are more problematic than the Opinion suggests (I have analysis on it forthcoming) however on the ECHR side of things, the Opinion could not be more correct. An outright ban on unstunned slaughter in the name of animal welfare or otherwise would offend freedom of religious expression to such a degree that it simply must not pass.
The CJEU (General Court) sided with Sweden in T-521/14, concerning the failure, by the Commission, to adopt measures concerning the specification of scientific criteria for the determination of endocrine-disrupting properties.
To improve the free movement of biocidal products in the EU, while ensuring a high level of protection of human and animal health and the environment, the EU adopted Regulation 528/2012 concerning the making available on the market and use of biocidal products. It sets out the active substances which, in principle, cannot be approved. They include active substances which, on the basis of criteria to be established, are regarded as having endocrine-disrupting properties which may be harmful to humans, or which have been designated as having those properties. It also provides that, by 13 December 2013 at the latest, the Commission was to adopt the delegated acts as regards the specification of the scientific criteria for the determination of endocrine-disrupting properties.
The EC cited criticism following its presentation of draft scientific criteria, as well as the need to make the various possible solutions subject to an impact assessment. The CJEU first of all held that the Commission had a clear, precise and unconditional obligation to adopt delegated acts as regards the specification of the scientific criteria for the determination of the endocrine-disrupting properties and that that was to be done by 13 December 2013.
With respect to the impact assessment, the General Court finds that there is no provision of the regulation which requires such an impact analysis. What is more, even if the Commission ought to have carried out such an impact analysis, that does not in any way exonerate it, in the absence of provisions to that effect, from complying with the deadline set for the adoption of those delegated acts.
I like this judgment (it will no doubt be appealed by the EC). It reinforces the need to respect clearly defined dates and deadlines. And it takes a bit of the shine off impact assessments, the duration, extend, and lobbying of which can often lead to death by impact analysis.